CLINICAL TRIAL TO EVALUATE THE EFFICIENCY OF PYRPHENIDONE FOR THE REDUCTION OF PULMONARY INFLAMMATION IN PATIENTS WITH SILICOSIS AND PROGRESSIVE MASSIVE FIBROSIS.

Phase 1

• Conditions: progressive massive fibrosis; MedDRA version: 20.0Level: PTClassification code 10040678Term: SilicosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 21.1Level: PTClassification code 10036805Term: Progressive massive fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-002701-94-ES
• Lead Sponsor: Fundación para la Gestión de la Investigación Biomédica de Cádiz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Age over 18 years and under 65.
2. Man with a diagnosis of silicosis in the form of PMF by lung or lymph node biopsy, or by radiological criteria.
3. History of exposure to silica in work with artificial can for at least 5 years.
4. Patients capable of consenting to their participation in the study by providing written informed consent, or, if they are not trained, through a legal repressentative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participation in another clinical trial in the 6 months prior to the start of participation in this study.
2. Hypersensitivity to any of the components of pirfenidone.
3. Biological or farmacological treatment for any other disease or condition related to silicosis or PMF.
4. Concomitant treatment with a drug that can causes pirfenidone interactions.
5. Active infectious disease
6. Any pathology that may condition the evolution of respiratory diseases, including cancer, HIV, HBV, HCV, liver cirrhosis, liver failure, severe kidney failure or any other that in the opinion of the investigator may interfere with the results of the study.
7. Active smoking
8. Laboratory test abnormalities at screening timepoint
- Total bilirrubin >2 ULN
- AST/SGOT or ALT/SGPT > 2.5 ULN
- Alkaline phosphatase >3.0 ULN
- Creatinine clearance <40 mL/min (Cockcroft-Gault)
9. Concomitant treatments that may cause serious digestive events.
10. Digestive surgery or similar procedures that may cause digestive intolerances.
11. Not availability to complete all the trial visits
12. Angiodema

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified